A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

Study Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Life expectancy of at least 12 weeks.

- Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody.

- Documented evidence of progressive disease on or after the last prior therapy, or participants who were intolerant to the last prior therapy.

- Measurable disease, as defined by the protocol.

- Participants agree to follow contraception or abstinence requirements as defined in the protocol.

Exclusion Criteria:

- Any anti-cancer therapy within 3 weeks prior to initiation of study treatment with exception defined by the protocol.

- Participants with autologous stem cell transplantation (SCT) within 100 days prior to first dose of study treatment.

- Participants with prior allogeneic SCT or solid organ transplantation.

- Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) - Active or history of autoimmune disease.

- Participants with current or history of Central Nervous System (CNS) disease, or current CNS involvement by Multiple Myeloma (MM) - Significant cardiovascular disease.

- Participants with known clinically significant liver disease.

- Symptomatic active pulmonary disease requiring supplemental oxygen.

- Known active infection requiring intravenous anti-microbial therapy within 14 days prior to first study drug administration.

- Any episode of active, symptomatic COVID-19 infection, or requiring treatment with IV antivirals for COVID-19 (not including COVID-19 primary prophylaxis) within 14 days, prior to first study treatment.

- Other protocol defined inclusion/exclusion criteria may apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05646836
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Genentech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Denmark, Greece, Israel, Korea, Republic of, Norway, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Arms & Interventions

Arms

Experimental: Arm A: Dose-Escalation and Expansion: XmAb24306+Cevostamab

Participants will receive escalating doses of XmAb24306 with a fixed dose regimen for cevostamab up to the maximum tolerated dose (MTD). After dose escalation has been completed, up to two expansion cohorts each investigating different XmAb24306 doses in combination with cevostamab may be enrolled.

Experimental: Arm B: Single-Agent Cevostamab Expansion

Participants will receive cevostamab alone.

Interventions

Drug: - Cevostamab

Cevostamab will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Drug: - XmAb24306

XmAb24306 will be administered intravenously on a 28-day cycle, for up to one year of treatment depending on clinical response.

Drug: - Tocilizumab

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.